The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery

Not Applicable

Completed

• Conditions: Spinal Stenosis
• Interventions: Drug: control group; Drug: dexmedetomidine group

• Registration Number: NCT02902380
• Lead Sponsor: Yonsei University

Brief Summary

Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-11
• Study First Posted: 2016-09-15
• Study Start: 2016-09-27
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
• patient scheduled for major spine surgery

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Exclusion Criteria

• ASA physical status Ⅳ
• congestive heart failure
• severe hepatorenal disease
• insulin dependent DM(diabetes mellitus)
• cancer or metastasis
• pregnancy
• problem with communication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	control group	0.9% saline infusion
Dexmedetomidine Group	dexmedetomidine group	dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery

Primary Outcome Measures

Name	Time	Method
Stress hormone level	1 hour after the end of surgery	The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of